Using brain stimulation to help reduce smoking
Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study
NA · Wake Forest University Health Sciences · NCT05460676
This study is testing whether a brain stimulation technique can help people who smoke reduce their cigarette use and manage stress while trying to quit.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05460676 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using Transcranial Direct Current Stimulation (tDCS) on the Dorsolateral Prefrontal Cortex (DLPFC) to help participants reduce cigarette smoking and manage distress. A total of 46 participants who smoke at least five cigarettes per day and are interested in quitting will be recruited. The study will involve interventions including tDCS, mindfulness practices, and a sham stimulation for comparison. Participants will complete online questionnaires and receive support through telehealth methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-75 who smoke at least five cigarettes daily and are motivated to quit within the next 30 days.
Not a fit: Patients who are unable to comply with study procedures or have significant health changes during the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could provide a novel method for aiding smoking cessation and reducing associated distress.
How similar studies have performed: While the use of tDCS for smoking cessation is a relatively novel approach, preliminary studies have shown promise in similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 21-75 years old * Smoke ≥5 cigarettes per day and express interest in quitting smoking in next 30 days * Mild to moderate distress defined as K10 scores 10-35 * Self reported previous diagnosis of cancer * Psychotropic medication stable for ≥1 month prior to enrollment and throughout the trial, at the discretion of the study physician * Access to a reliable internet connection, able to use mobile device, and complete online questionnaires, competent in instrumental activities of daily living * Able to read and understand informed consent and questionnaires in English (WRAT-4 score≥85) Exclusion Criteria: * Inability to effectively use study-provided supplies * Chronic non-compliance with study procedures * Changes in health information over the course of enrollment in the study which place the participant at higher risk for an adverse event (as determined by Study Physician or Principal Investigator; e.g. medication changes, invasive procedures) * Temporary or permanent obstructions to making contact between the electrodes and the scalp (e.g. wig that the participant is not willing to remove) * History of traumatic brain injury, brain metastases, seizure disorder, recent (\<5 years) seizure history, or a neurodegenerative disease or neurocognitive disorder associated with significant impairment (e.g. Parkinson's, Dementia) * Current severe major depressive disorder, lifetime history of psychotic disorders or bipolar disorder type I, or current suicidal ideation * Currently meets DSM-5 criteria for severe substance use disorder in the past 6 months for any psychoactive substance other than tobacco * Current suicidal ideation (as determined by the MINI) * Current use of prescription or over the counter smoking cessation medication, or primary use of non-combustible forms of nicotine/tobacco * Currently receiving intravenous chemotherapy or radiation treatments * Presence of metal objects in the head/neck * Any skin disorder or skin sensitive area near stimulation locations * Self-reported pregnancy * Enrolled in group or individual therapy for smoking cessation that would be concurrent to intervention
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Merideth A Addicott, Ph.D. — Wake Forest University Health Sciences
- Study coordinator: Hilary R Smith
- Email: hsmith@wakehealth.edu
- Phone: 336-716-5181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Smoking Cessation, cigarette, smoking, cancer, anxiety, stress, tobacco, mindfulness